Events

Recall of Device Recall Infant Radiant Warmer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77287
  • Event Risk Class
    Class 2
  • Event Number
    Z-2323-2017
  • Event Initiated Date
    2017-05-05
  • Event Date Posted
    2017-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155625
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Warmer, infant radiant - Product Code FMT
  • Reason
    Ge healthcare has recently become aware of a potential safety issue related to loose screws in the heater head of the infant warmer system (iws). hot screws from the heater head of the iws could fall onto the bed if the heater head assembly has been improperly serviced. this situation can be clinically hazardous because thermal injury to a patient could result. two injuries have been reported as a result of this issue.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter dated May 5, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Product Correction : Attached to this letter, we provide instructions as part of a Service Manual Addendum on how to correct the issue. Please add this new Addendum to the Service Manual of your device(s) and train the affected users accordingly. Please acknowledge that you have received this letter and that you understand that an action needs to be taken on your part to correct this issue by filling out and returning the attached Customer Response form. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.

Device

Device Recall Infant Radiant Warmer
  • Model / Serial
    Medical device listing number: D103053, D103054, D103056, D103057, D183529
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution.
  • Product Description
    Infant Warmer System (IWS)
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA